a study of bl-m17d1 in patients with locally advanced or metastatic her2 positive/lower expression gastrointestinal cancer and other solid tumors

Conditions: Esophageal Cancer; Gastric Cancer; Pancreatic Cancer; Colorectal Cancer; Solid Tumor

Summary: this study is an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase i clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of bl-m17d1 in locally advanced or metastatic her2 positive/lower expression gastrointestinal cancer and other solid tumors.


Eligibility criteria:
inclusion criteria: 1. voluntarily sign the informed consent and follow the requirements of the protocol; 2. no gender limit; 3. age: ≥18 years old and ≤75 years old (stage ia); ≥18 years old (stage ib); 4. expected survival time ≥3 months; 5. the pathologic histology and/or cytology diagnosis of locally advanced or metastatic positive her2 / low expression of the digestive tract tumor and other solid tumor; 6. consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 years; 7. must have at least one measurable lesion according to recist v1.1 definition; 8. ecog 0 or 1; 9. toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by nci-ctcae v5.0; 10. no severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 11. organ function level must meet the requirements; 12. coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5uln; 13. urine protein ≤2+ or ≤1000mg/24h; 14. for premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and must be non-lactating; all the patients (no matter male or female) shall be 6 months after the end of the treatment period and full barrier precautions. exclusion criteria: 1. anti-tumor therapy such as chemotherapy or biological therapy has been used within 4 weeks or 5 half-lives before the first dose; mitomycin and nitrosoureas were administered within 6 weeks before the first dose; oral drugs such as fluorouracil; 2. history of severe heart disease; 3. qt prolongation, complete left bundle branch block, iii degree atrioventricular block, frequent and uncontrollable arrhythmia; 4. active autoimmune and inflammatory diseases; 5. other malignant tumors diagnosed within 5 years before the first dose; 6. hypertension poorly controlled by two antihypertensive drugs; 7. patients with poor glycemic control before the first dose; 8. have to hormone treatment of interstitial lung disease, or the current with ild or suspected suffering from such diseases; 9. complicated pulmonary diseases leading to clinically severe respiratory function impairment; 10. patients with massive or symptomatic effusions or poorly controlled effusions; 11. imaging examination showed that the tumor had invaded or wrapped around the chest, neck, pharynx and other large blood vessels; 12. screening for unstable thrombotic events requiring therapeutic intervention within the preceding 6 months; 13. patients with active central nervous system metastases; 14. patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of the excipients of bl-m17d1; 15. prior organ transplantation or allogeneic hematopoietic stem cell transplantation; 16. hiv antibody positive, active tuberculosis, active hepatitis b virus infection, or active hepatitis c virus infection; 17. active infection requiring systemic therapy with serious infection within 4 weeks before informed consent; there were indications of pulmonary infection or active pulmonary inflammation within 2 weeks before informed consent; 18. participated in another clinical trial within 4 weeks before the first dose; 19. pregnant or lactating women; 20. patients with superior vena cava syndrome should not be rehydrated; 21. a history of severe neurological or psychiatric illness; 22. severe unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent; 23. subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent; 24. history of intestinal obstruction, inflammatory bowel disease, or extensive bowel resection or presence of crohn's disease, ulcerative colitis, or chronic disease sexual diarrhea; 25. patients scheduled for vaccination or receiving live vaccine within 28 days before the first dose; 26. other conditions for participation in the trial were not considered appropriate by the investigator.